Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-02-02
2024-08-01
Brief Summary
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Objective: The purpose of this study was to evaluate the analgesic efficacy of ultrasound-guided SPSIPB compared with subcutaneous morphine administration in patients undergoing VATS.
Methods: In this prospective, randomized controlled trial, 60 patients scheduled for elective VATS were randomized into two groups: SPSIPB group (n=30) and control group receiving subcutaneous morphine (n=30). The primary outcome was postoperative pain intensity measured by the visual analog scale (VAS) at rest and during coughing. Secondary outcomes included opioid consumption, number of patient-controlled analgesia (PCA) demands, rescue analgesia requirements, and incidence of adverse effects.
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Detailed Description
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Effective postoperative analgesia after thoracic surgery is essential to prevent pulmonary complications, enhance recovery, and improve patient satisfaction. Although thoracic epidural analgesia has traditionally been considered the gold standard, its use is limited due to potential complications such as hypotension, urinary retention, and technical difficulties. With the increased use of minimally invasive thoracic procedures, including video-assisted thoracoscopic surgery (VATS), safer and less invasive analgesic techniques are being explored.
The serratus posterior superior intercostal plane block (SPSIPB) is a newly described regional anesthesia technique that targets the posterior thoracic intercostal nerves. Preliminary evidence suggests that SPSIPB may provide effective postoperative analgesia while minimizing procedure-related risks.
Objective:
The aim of this study was to evaluate the analgesic efficacy and safety of ultrasound-guided SPSIPB compared with subcutaneous morphine injection for postoperative pain management in patients undergoing VATS.
Study Design:
This was a prospective, randomized controlled, single-center clinical trial conducted at Gaziantep University Faculty of Medicine, Department of Anesthesiology. Sixty patients scheduled for elective VATS under general anesthesia were enrolled. After obtaining informed consent, patients were randomly allocated into two groups:
SPSIPB Group (n = 30): Patients received an ultrasound-guided serratus posterior superior intercostal plane block with 20 mL of local anesthetic at the end of surgery.
Control Group (n = 30): Patients received subcutaneous morphine injection according to institutional standard practice.
Outcome Measures:
The primary outcome was postoperative pain intensity assessed by the Visual Analog Scale (VAS) at rest and during coughing at multiple time points within the first 24 hours after surgery. Secondary outcomes included total opioid consumption within 24 hours, the number of patient-controlled analgesia (PCA) demands, the need for rescue analgesia, and the incidence of adverse events such as nausea, vomiting, respiratory depression, or block-related complications.
Significance:
This study will contribute to the growing evidence on interfascial plane blocks in thoracic surgery. If proven effective, SPSIPB may serve as a safe and valuable alternative to conventional analgesic methods, reducing opioid consumption and related side effects in patients undergoing VATS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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SPSIPB Group
Patients received an ultrasound-guided SPSIPB with 20 mL local anesthetic at the end of surgery.
Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block
Intervention Type: Procedure (Regional Anesthesia) Name: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) Description: A single injection of 20 mL of local anesthetic was administered under ultrasound guidance into the serratus posterior superior intercostal plane at the end of surgery.
Active Comparator
Patients received a subcutaneous morphine injection according to institutional standard practice after surgery.
Subcutaneous Morphine
Intervention Type: Drug (Morphine) Name: Subcutaneous Morphine Description: Patients received a single subcutaneous injection of morphine (dose according to institutional standard practice) after surgery.
Interventions
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Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block
Intervention Type: Procedure (Regional Anesthesia) Name: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) Description: A single injection of 20 mL of local anesthetic was administered under ultrasound guidance into the serratus posterior superior intercostal plane at the end of surgery.
Subcutaneous Morphine
Intervention Type: Drug (Morphine) Name: Subcutaneous Morphine Description: Patients received a single subcutaneous injection of morphine (dose according to institutional standard practice) after surgery.
Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologists (ASA) physical status I-III
3. Scheduled for elective video-assisted thoracoscopic surgery (VATS) under general anesthesia
4. Provision of written informed consent
Exclusion Criteria
2. Coagulopathy or ongoing anticoagulant therapy
3. Local infection at the injection site
4. Known allergy to local anesthetics or morphine
5. Severe cardiopulmonary disease contraindicating regional anesthesia
6. Refusal to participate in the study
18 Years
70 Years
ALL
No
Sponsors
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University of Gaziantep
OTHER
Responsible Party
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Elzem SEN
Assoc. Prof.
Principal Investigators
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Elzem Şen, Assoc. Prof
Role: PRINCIPAL_INVESTIGATOR
University of Gaziantep
Locations
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Gaziantep University
Gaziantep, , Turkey (Türkiye)
Countries
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Other Identifiers
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2023/376
Identifier Type: -
Identifier Source: org_study_id
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